Manipulating E-Cigarette Nicotine to Promote Public Health

NCT06448351 | Recruiting

• 2 other identifiers: OSU-23143NCI-2023-05712
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (24)

• Nicotine pharmacokinetics: Maximum nicotine blood level (Cmax) (Study 1)

  Blood nicotine samples will be assayed using liquid chromatography tandem mass spectrometry (LC-MS/MS) with deuterated internal standards.

  Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session

• Nicotine pharmacokinetics: Time to maximum blood level (Tmax) (Study 1)

  Blood nicotine samples will be assayed using LC-MS/MS with deuterated internal standards.

  Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session

• Nicotine pharmacokinetics: Area under the curve (AUC) (Study 1)

  Blood nicotine samples will be assayed using LC-MS/MS with deuterated internal standards.

  Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session

• Nicotine metabolism (Study 1)

  The rate of nicotine metabolism will be assessed using the standard method of nicotine metabolite ration (NMR) = hydroxycotinine/cotinine, modified to reflect stereoselective metabolism. Plasma concentration of cotinine, and hydroxycotinine will be measured by chiral LC-MS/MS based on previous methods and quantified using the ratio of metabolites to internal standards.

  At 60 minutes after the start of each puffing session

• Reactive oxygen species (ROS) (Study 1)

  The recorded puffing topographies will be sent to the analytical lab for "puff playback" generation of EC aerosols and quantification of ROS. We will use an acellular ROS assay previously developed by our team as a generic toxicity assessment method.

  Up to 2 years

• Nicotine toxicity measures (Study 1)

  Will be assessed by carbonyl yields reported as ug/session or ug/puff or normalized per nicotine yield for a head-to-head comparison between different nicotine conditions.

  Up to 2 years

• In vitro nicotine toxicity measures: Cell cycle and proliferation (Study 1)

  Will be assessed by cell cycle and proliferationg.

  Up to 2 years

• In vitro nicotine toxicity measures: Cytotoxicity (Study 1)

  Will be assessed by cytotoxicity, senescence.

  Up to 2 years

• In vitro nicotine toxicity measures: Senescence (Study 1)

  Will be assessed by senescence.

  Up to 2 years

• In vitro nicotine toxicity measures: RNA sequencing (Study 1)

  Will be assessed by RNA sequencing.

  Up to 2 years

• Nicotine yield (Study 1)

  Using a dilute-and-shoot method developed by our team, nicotine yield in EC aerosol will be quantified using the "playback" technique (i.e., use topography collected from participants to machine-generate EC aerosols) and GC-MS method, developed by our group to minimize the PG/VG interference not addressed by other methods.

  Up to 2 years

• Modified Cigarette Evaluation Questionnaire (mCEQ)(Study 1)

  The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses. The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, and craving reduction.

  Study visits 2 through 9

• Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)

  Smoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette") for EC users. This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.

  Study visits 2 through 9

• Drug Effects/Liking Questionnaire (DEQ)(Study 1)

  Assess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)

  Study visits 2 through 9

• Minnesota Nicotine Withdrawal Scale (MNWS)(Study 1)

  Asses Nicotine withdrawal and smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal (MNWS) or more craving to smoke (MNWS Craving).

  Study visits 2 through 9

• Puffing topography: Puff count (Study1)

  Puff count will be measured.

  60 minute puffing session at each of the 8 study lab visits

• Puffing topography: Average puff duration (Study1)

  Average puff duration will be measured.

  60 minute puffing session at each of the 8 study lab visits

• Puffing topography: inter-puff interval (Study1)

  Inter-puff interval will be measured.

  60 minute puffing session at each of the 8 study lab visits

• Puffing topography: Flow rate (Study1)

  Flow rate will be measured.

  60 minute puffing session at each of the 8 study lab visits

• Puffing topography: Volume (Study1)

  Puff volume will be measured.

  60 minute puffing session at each of the 8 study lab visits

• General Labeled Magnitude Scale (gLMS) (Study 2)

  Complete the General Labeled Magnitude Scale (gLMS) after each condition. Scores range from 0 "No Sensation" to 100 "Strongest Imaginable".

  1 six hour lab visit

• Labeled Hedonic Scale (LHS) (Study 2)

  Complete the Labeled Hedonic Scale (LHS) after each condition. Scores range from -100 "Most Disliked Imaginable" to 100 "Most Liked Imaginable".

  1 six hour lab visit

• Sensory Attributes (Study 2)

  Rate sensory attributes (smoothness, harshness, sweetness, bitterness) on a 100-unit visual analog scale after each condition.

  1 six hour lab visit

• Overall acceptance: Industry-designed Thermometer Rating Scale (Study 2)

  Complete a tobacco industry-designed thermometer rating scale of overall acceptance after each condition. Ratings range from 0 "the very worst" to 100 "the very best", with 50 indicating "indifferent".

  1 six hour lab visit

Study Arms (28)

Phase 1, Arm 1 (High, Nic, S)

EXPERIMENTAL

Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 1, Arm 2 (High, Nic, R/S)

EXPERIMENTAL

Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 1, Arm 3 (Low, Nic, S)

EXPERIMENTAL

Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 1, Arm 4 (Low, Nic, R/S)

EXPERIMENTAL

Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 1, Arm 5 (High, NicH+, S)

EXPERIMENTAL

Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 1, Arm 6 (High, NicH+, R/S)

EXPERIMENTAL

Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 1, Arm 7 (Low, NicH+, S)

EXPERIMENTAL

Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 1, Arm 8 (Low, NicH+, R/S)

EXPERIMENTAL

Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 1 (High, 5%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 2 (High, 5%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 3 (Low, 5%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 4 (Low, 5%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 5 (High, 25%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 6 (High, 25%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 7 (Low, 25%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 8 (Low, 25%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 9 (High, 45%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 10 (High, 45%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 11 (Low, 45%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 12 (Low, 45%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 13 (High , 65%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 14 (High , 65%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 15 (Low, 65%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 16 (Low, 65%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 17 (High, 85%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 18 (High, 85%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 19 (Low, 85%, S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Phase 2, Arm 20 (Low, 85%, R/S)

EXPERIMENTAL

Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.

Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration

Interventions

Carbon Monoxide Measurement PROCEDURE

Undergo CO test

Also known as: Carbon Monoxide, CMONOX

Phase 1, Arm 1 (High, Nic, S); Phase 1, Arm 2 (High, Nic, R/S); Phase 1, Arm 3 (Low, Nic, S); Phase 1, Arm 4 (Low, Nic, R/S); Phase 1, Arm 5 (High, NicH+, S); Phase 1, Arm 6 (High, NicH+, R/S); Phase 1, Arm 7 (Low, NicH+, S); Phase 1, Arm 8 (Low, NicH+, R/S); Phase 2, Arm 1 (High, 5%, S); Phase 2, Arm 10 (High, 45%, R/S); Phase 2, Arm 11 (Low, 45%, S); Phase 2, Arm 12 (Low, 45%, R/S); Phase 2, Arm 13 (High , 65%, S); Phase 2, Arm 14 (High , 65%, R/S); Phase 2, Arm 15 (Low, 65%, S); Phase 2, Arm 16 (Low, 65%, R/S); Phase 2, Arm 17 (High, 85%, S); Phase 2, Arm 18 (High, 85%, R/S); Phase 2, Arm 19 (Low, 85%, S); Phase 2, Arm 2 (High, 5%, R/S); Phase 2, Arm 20 (Low, 85%, R/S); Phase 2, Arm 3 (Low, 5%, S); Phase 2, Arm 4 (Low, 5%, R/S); Phase 2, Arm 5 (High, 25%, S); Phase 2, Arm 6 (High, 25%, R/S); Phase 2, Arm 7 (Low, 25%, S); Phase 2, Arm 8 (Low, 25%, R/S); Phase 2, Arm 9 (High, 45%, S)

Biospecimen Collection PROCEDURE

Undergo blood and urine sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Phase 1, Arm 1 (High, Nic, S); Phase 1, Arm 2 (High, Nic, R/S); Phase 1, Arm 3 (Low, Nic, S); Phase 1, Arm 4 (Low, Nic, R/S); Phase 1, Arm 5 (High, NicH+, S); Phase 1, Arm 6 (High, NicH+, R/S); Phase 1, Arm 7 (Low, NicH+, S); Phase 1, Arm 8 (Low, NicH+, R/S); Phase 2, Arm 1 (High, 5%, S); Phase 2, Arm 10 (High, 45%, R/S); Phase 2, Arm 11 (Low, 45%, S); Phase 2, Arm 12 (Low, 45%, R/S); Phase 2, Arm 13 (High , 65%, S); Phase 2, Arm 14 (High , 65%, R/S); Phase 2, Arm 15 (Low, 65%, S); Phase 2, Arm 16 (Low, 65%, R/S); Phase 2, Arm 17 (High, 85%, S); Phase 2, Arm 18 (High, 85%, R/S); Phase 2, Arm 19 (Low, 85%, S); Phase 2, Arm 2 (High, 5%, R/S); Phase 2, Arm 20 (Low, 85%, R/S); Phase 2, Arm 3 (Low, 5%, S); Phase 2, Arm 4 (Low, 5%, R/S); Phase 2, Arm 5 (High, 25%, S); Phase 2, Arm 6 (High, 25%, R/S); Phase 2, Arm 7 (Low, 25%, S); Phase 2, Arm 8 (Low, 25%, R/S); Phase 2, Arm 9 (High, 45%, S)

Vaping session OTHER

Sample study e-liquids in vaping sessions at research lab with e-cig study device

Also known as: Vaping e-liquid

Phase 1, Arm 1 (High, Nic, S); Phase 1, Arm 2 (High, Nic, R/S); Phase 1, Arm 3 (Low, Nic, S); Phase 1, Arm 4 (Low, Nic, R/S); Phase 1, Arm 5 (High, NicH+, S); Phase 1, Arm 6 (High, NicH+, R/S); Phase 1, Arm 7 (Low, NicH+, S); Phase 1, Arm 8 (Low, NicH+, R/S); Phase 2, Arm 1 (High, 5%, S); Phase 2, Arm 10 (High, 45%, R/S); Phase 2, Arm 11 (Low, 45%, S); Phase 2, Arm 12 (Low, 45%, R/S); Phase 2, Arm 13 (High , 65%, S); Phase 2, Arm 14 (High , 65%, R/S); Phase 2, Arm 15 (Low, 65%, S); Phase 2, Arm 16 (Low, 65%, R/S); Phase 2, Arm 17 (High, 85%, S); Phase 2, Arm 18 (High, 85%, R/S); Phase 2, Arm 19 (Low, 85%, S); Phase 2, Arm 2 (High, 5%, R/S); Phase 2, Arm 20 (Low, 85%, R/S); Phase 2, Arm 3 (Low, 5%, S); Phase 2, Arm 4 (Low, 5%, R/S); Phase 2, Arm 5 (High, 25%, S); Phase 2, Arm 6 (High, 25%, R/S); Phase 2, Arm 7 (Low, 25%, S); Phase 2, Arm 8 (Low, 25%, R/S); Phase 2, Arm 9 (High, 45%, S)

Survey Administration OTHER

Ancillary studies

Phase 1, Arm 1 (High, Nic, S); Phase 1, Arm 2 (High, Nic, R/S); Phase 1, Arm 3 (Low, Nic, S); Phase 1, Arm 4 (Low, Nic, R/S); Phase 1, Arm 5 (High, NicH+, S); Phase 1, Arm 6 (High, NicH+, R/S); Phase 1, Arm 7 (Low, NicH+, S); Phase 1, Arm 8 (Low, NicH+, R/S); Phase 2, Arm 1 (High, 5%, S); Phase 2, Arm 10 (High, 45%, R/S); Phase 2, Arm 11 (Low, 45%, S); Phase 2, Arm 12 (Low, 45%, R/S); Phase 2, Arm 13 (High , 65%, S); Phase 2, Arm 14 (High , 65%, R/S); Phase 2, Arm 15 (Low, 65%, S); Phase 2, Arm 16 (Low, 65%, R/S); Phase 2, Arm 17 (High, 85%, S); Phase 2, Arm 18 (High, 85%, R/S); Phase 2, Arm 19 (Low, 85%, S); Phase 2, Arm 2 (High, 5%, R/S); Phase 2, Arm 20 (Low, 85%, R/S); Phase 2, Arm 3 (Low, 5%, S); Phase 2, Arm 4 (Low, 5%, R/S); Phase 2, Arm 5 (High, 25%, S); Phase 2, Arm 6 (High, 25%, R/S); Phase 2, Arm 7 (Low, 25%, S); Phase 2, Arm 8 (Low, 25%, R/S); Phase 2, Arm 9 (High, 45%, S)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current exclusive young adult EC user for at least the past 3 months (confirmed by cotinine testing strip) between 21-24 years old with no/minimal history of smoking cigarettes (≤ 10 cigarettes in entire life)
• Current older adult smoker (daily use, ≥ 100 cigarettes in entire life) aged 25-65 with interest in trying an EC
• Willing to abstain from all nicotine, tobacco products, and marijuana for at least 12 hours before study visits
• Read and speak English

You may not qualify if:

• Currently attempting to quit nicotine or tobacco products
• Currently pregnant (will be verified with urine pregnancy test), planning to become pregnant, or breastfeeding
• If age 21-24 years old AND use of any tobacco products other than ECs (use of \>10 cigarettes in entire life; use of \>10 traditional cigars, cigarillos, or filtered cigars in entire life; use of smokeless tobacco products \>10 times in entire life; or hookah in the last 30 days).
• Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
• New or unstable cardiovascular disease diagnosed within the past 3 months
• Use of medications that are inducers of CYP2A6 enzyme such as rifampicin, dexamethasone, phenobarbital, and other anti-convulsion drugs

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Interventions

Specimen Handling; Carbon Monoxide

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• Theodore L Wagener

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Personnel performing the assays will be blinded to the status of the sample.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 7, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: April 21, 2026

Record last verified: 2025-05

Locations

US (1)